Balloon system and methods for treating obesity

ABSTRACT

A medical system for the treatment of morbid obesity comprising an inflatable balloon implanted in a gastric cavity, a percutaneous fillant delivery tube and a control module connected to the tube for regulating the inflation and deflation of the balloon. The balloon may be individually contoured and inflated to occupy a large volume of the gastric cavity to provide a feeling of satiety. The balloon may also be deflated to give the gastric cavity lining a rest during less critical time.

RELATED APPLICATION

This application is a continuation-in-part application of and claims thebenefit and priority of U.S. patent application Ser. No. 10/513,583,filed Nov. 2, 2004, and a continuation-in-part application of and claimsthe benefit and priority of U.S. patent application Ser. No. 12/257,724,filed Oct. 24, 2008, the contents of which are incorporated by referenceherein in its entirety.

BACKGROUND Field

This invention generally relates to the treatment of morbid obesity and,more specifically, to a system and method for treating morbid obesityusing a variably cycled percutaneous balloon implanted in the gastriccavity.

General Background

Morbid obesity is a major health problem confronting the general publicand health care industry today. It is estimated that approximately 50%of the U.S. population is overweight and over ten million Americans aremore than 100 pounds over their ideal weight. Generally, a person isconsidered morbidly (or seriously) obese if they are 100 pounds or moreover their ideal weight. The morbidly obese group faces increased healthrisks including a higher likelihood of heart disease, hypertension,diabetes and certain cancers. Over 300,000 Americans die of obesityrelated illnesses each year. In addition, the morbidly obese generallyhave lower self-esteem and are more likely to suffer from depressionthan the general public.

Most obese individuals have struggled unsuccessfully with their weightfor a lifetime. The numerous diets, behavioral therapy and treatmentssuch as hypnosis, pituitary hormones and appetite suppressant drugsattest to the great difficulty many overweight people have in losingweight and keeping it off. Some of these weight loss strategies can besuccessful in the mildly obese people, but nearly all fail inindividuals considered morbidly obese. These disappointing results haveled many patients and their doctors to consider surgery as an option forweight loss.

Surgical techniques bring about weight loss primarily by limiting howmuch the stomach can hold. Today's most common surgical procedures topromote weight loss focus on decreasing food intake by restriction.Gastric banding, gastric bypass and vertical-banded gastroplasty aresurgeries that limit the amount of food the stomach can hold by closingoff or removing parts of the stomach. Other surgeries attempt topermanently fill the stomach with an inflated balloon. These treatmentsare invasive, require major surgery with hospitalization and areassociated with complications.

The success rates of current treatments and procedures have been poor.With the restrictive procedure, the patient is usually limited to eatingvery small amounts of food at a time. For many people, this can create a“satisfied” feeling, but they often do not feel “full”. The ability toeat a large amount of food at one time is lost; consequently, manypatients return to eating excessive amounts of high calorie or highsugar liquid foods. Essentially, their diet includes milk shakes and icecream.

As to the balloon procedure of the past, very limited positive resultswere achieved. The balloon was relatively small when compared to theoverall volume of the morbidly obese stomach. This is due tophysiological limitation on the balloon volume. That is, complicationsof the device precluded enlarging it to a volume that would occupy moreof the stomach. Yet, in order for the balloon to achieve a patient'sfeeling of fullness and satiation, the balloon would need to occupy alarge portion (volume) of the patient's stomach. A balloon occupyingthis much volume without fixation or an inflation/deflation cycling hasthe potential of blocking food flow and causing necrosis of the stomachwall, ulcers and/or bleeding.

Moreover, success depends on the ability of a treatment to “normalize”not only the mechanical and neurohormonal sensation of feeling full andsatiated, but also involves psychological factors. Both the mechanicaland neurohormonal factors relate to one's need to feel “full” and“satiated”. Chemicals released by the stomach during the digestiveprocess largely drive these factors. In other words, filling the stomachor limiting its pouch size controls these chemicals. Current surgicalapproaches, however, fail to achieve this global feeling of “satiety”response as they restrict food entry only into the small proximalstomach pouch and bypass the distal stomach where most of theneurohormonal chemical are normally released. Medical therapy is focusedalmost exclusively at the brain level and is likely to continue to failas patients experience mood disorders and complications frommedications. Accordingly, there is a need for a system and method fortreating morbid obesity by restoring or normalizing the appropriate“fullness signals” from the stomach itself as this is the organ thatregulates fullness. In particular, the system and method of theinvention should cause a feeling of satiety from the stomach itself withless consumption of food by a morbidly obese patient.

SUMMARY

A system and method for treating morbid obesity using a variably cycledpercutaneous balloon implanted in the gastric cavity to elicit signalsdirectly from the entire stomach in order to cause a feeling of satietywith less food. This novel approach has the potential to offer a lessinvasive, more complete elicitation of the feeling of fullness inpatients who chronically, and perhaps genetically overeat. The system ofthe invention includes a balloon device that is contoured to occupy thevast majority of the volume of the stomach. The system also has thecapacity to automatically inflate and deflate the balloon, therebyavoiding the problem of pressure induced injury. With the advent of CTscanning and 3-dimensional imaging, patients may have balloonsindividually designed to meet the specific morphologic features of theirstomachs. By fixation of the balloon device, the problems of migrationand obstruction are avoided. Furthermore, the system and process of theinvention apply appropriate inflation/deflation cycling with acomputerized device so as to avoid complications of past devices.

These and other features and advantages of the invention will becomemore apparent with a discussion of preferred embodiments in reference tothe associated drawings.

DRAWINGS

FIG. 1 illustrates a schematic view of a variably cycled percutaneousballoon placed within the gastric cavity of an individual in accordancewith an embodiment of the invention; and

FIG. 2 illustrates a cross-sectional view of an inflatable balloon and afillant delivery tube according to the present invention.

DETAILED DESCRIPTION

With reference to FIGS. 1 and 2, a variably cycled percutaneous balloonsystem 100 for treating morbid obesity is illustrated and comprises aninflatable balloon no individually contoured to each patient's stomach,a percutaneous inflation or fillant delivery tube 120 having a proximalend and a distal end connected to the balloon no, and a control module130 connected to the proximal end of the tube 120. The tube 120 includesat least one opening 115 for filling the balloon 110 with abiocompatible fillant. The control module 130 variably controls theinflation and deflation of the balloon no with the biocompatible fillantsuch as a liquid, gas, gel or a mixture thereof. In accordance with theteachings of the present invention, the tube 120 is passed through andaffixed to abdominal wall 160 and stomach wall 150. The balloon no isthen positioned into the stomach or gastric cavity 140. The positioningof the balloon 110 may be done, e.g., by the percutaneous endoscopicgastrostomy (PEG) technique, which is known in the art. The balloon noand tube 120 may be separate or integral components that are constructedfrom any surgical grade material. For example, the balloon no may bemade from latex rubber which expands upon introduction of a fillant, andthe tube 120 may be constructed of a metal or plastic material. The tube120 is connected to the control module 130, which may be a fixed unit ora portable unit mounted to the patient's side. The control module 130may be a personal computer such as a desktop computer, a laptop computeror a handheld computer. The control module 130 further includes a devicesuch as a pump for introducing and removing a fillant to and from theballoon no.

A novel feature of the system 100 is it variably controls the inflationand deflation of the balloon no. For example, the system 100 may inflateand deflate the balloon no throughout a predetermined period of timesuch as a 24-hour period. The balloon no would occupy a large volume ofthe stomach 140 (as shown by reference number 110(a)) when it would bemost beneficial for weight loss, and deflate to give the stomach lininga rest (as shown by reference number 110(b)) during less critical time,e.g., during sleeping time. Furthermore, an algorithm tailored to eachpatient's needs and programmed into the control module 130 is used tocontrol the balloon size to minimize the desire to eat and to preventblockage or stomach lining necrosis. Unlike the restrictive proceduresof the prior art, the variable inflated balloon no would not limitnutrient absorption and not lead to altered food choices. This isachieved as the balloon no contacts a major portion of the stomach wall150 when the balloon no is fully inflated. Thus, the system 100 of theinvention creates a feeling of fullness and satiation by balancing thephysiological, neurohormonal and chemical factors.

It will be understood that many modifications can be made to thedisclosed embodiments without departing from the spirit and scope of theinvention. As such, the above description should not be construed aslimiting the invention, but should be interpreted as merely exemplary ofpreferred embodiments.

1-7. (canceled)
 8. A method to treat obesity, said method comprising:connecting a distal end of a fillant delivery tube to a balloon, saidfillant tube comprising a separate component with said distal end andproximal end; connecting said proximal end of said fillant delivery tubeto a control module, said control module including a pump forintroducing a fillant to said balloon; implanting said balloon in thepatient's stomach; using said control module and pump to automaticallyand fully inflate said balloon with said fillant, said fully inflatedballoon providing ac contour occupying the majority of the volume of thestomach; and said fully inflated balloon providing a balloon surfacecontacting a major portion of said stomach wall, wherein the inflatedballoon is configured to elicit a signal to cause a feeling of satiety.9. A method of claim 8 wherein the balloon is made from a surgical gradematerial.
 10. The method of claim 8 wherein the balloon i made fromrubber which expands upon introduction of said fillant.
 11. The methodof claim 8 wherein the tube is made from a surgical grade material. 12.The method of claim 8 wherein the tube is constructed of a metal orplastic material.
 13. The method of claim 8 wherein said feeling ofsatiety is from the stomach itself.
 14. The method of claim 8 whereinsaid feeling of satiety is created by balancing physiological,neurohormonal and chemical factors of said patient.
 15. A system fortreating obesity comprising: a. an inflatable elastomeric balloon havingdistal and proximal regions and adapted for implantation in a gastricspace; a fillant delivery tube extending through the balloon and affixedto the distal and proximal regions of the balloon, the tube terminatingat the distal region of the balloon; a control module connected to aproximal end of the tube and configured to cyclically inflate anddeflate the balloon across a plurality of cycles throughout apredetermined period of time according to a program; wherein the tubeimparts a reference shape to the deflated balloon; and wherein theballoon is configured to expand to a shape that is axially constrainedby the fillant delivery tube; wherein the balloon is individuallydesigned to meet specific morphologic features of a patient's stomachsuch that it is contoured to occupy the vast majority of a volume of thestomach in an inflated state.
 16. The system of claim 15, whereinballoon is filled with at least one gas, liquid, or gel.
 17. The systemof claim 15, wherein the uninflated balloon is a first size andconfigured to inflate with at least one gas, liquid and gel to a size atleast three times the size of the uninflated balloon size.